Trial Outcomes & Findings for Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy (NCT NCT01140867)

NCT ID: NCT01140867

Last Updated: 2022-01-04

Results Overview

The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 121 participants
• Primary outcome timeframe: Baseline and 16 weeks
• Results posted on: 2022-01-04

Participant Flow

This study was recruited at 10 centers in Korea during the period of February 2008 to August 2010.

Participant milestones

Measure	Zonisamide Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Overall Study STARTED	121
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Measure	Zonisamide Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Overall Study Adverse Event	22
Overall Study Lack of Efficacy	3
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1
Overall Study Uncooperative patient	2
Overall Study Medication Noncompliance	2

Baseline Characteristics

Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

Baseline characteristics by cohort

Measure	Zonisamide n=121 Participants Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Age, Continuous	37.70 years STANDARD_DEVIATION 11.19 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	121 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

Population: Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.

The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.

Outcome measures

Measure	Zonisamide n=102 Participants Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Seizure Reduction Rate	-16.35 Percentage of Seizure Reduction Rate Standard Deviation 436

SECONDARY outcome

Timeframe: 16 weeks

Population: Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.

The percentage of the participants who experienced no seizure during the trial.

Outcome measures

Measure	Zonisamide n=102 Participants Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Seizure Free Rate	24.51 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Population: Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.

The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.

Outcome measures

Measure	Zonisamide n=102 Participants Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Responder Rate	61.76 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Population: Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. Regarding QOLIE-31, among FAS population, the patients who have both of baseline and 16 week evaluation are included.

Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.

Outcome measures

Measure	Zonisamide n=102 Participants Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
QoL-QOLIE31 (Quality of Life in Epilepsy) 16 weeks - Post- QOLIE 31 total score (N=90)	57.70 Units on a Scale Standard Deviation 15.74
QoL-QOLIE31 (Quality of Life in Epilepsy) Baseline- Pre-QOLIE 31 total score (N=90)	56.67 Units on a Scale Standard Deviation 15.97

Adverse Events

Zonisamide

Serious events: 2 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zonisamide n=121 participants at risk Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Injury, poisoning and procedural complications Ligament rupture	0.83% 1/121 • Number of events 3
Injury, poisoning and procedural complications Brain contusion	0.83% 1/121 • Number of events 1
Injury, poisoning and procedural complications Rib fracture	0.83% 1/121 • Number of events 1
Injury, poisoning and procedural complications Skin laceration	0.83% 1/121 • Number of events 1
Infections and infestations Diverticulitis	0.83% 1/121 • Number of events 1

Other adverse events

Measure	Zonisamide n=121 participants at risk Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Nervous system disorders Dizziness	28.1% 34/121 • Number of events 37
Nervous system disorders Somnolence	24.0% 29/121 • Number of events 32
Nervous system disorders Headache	14.0% 17/121 • Number of events 23
Gastrointestinal disorders Vomiting	13.2% 16/121 • Number of events 16
Metabolism and nutrition disorders Anorexia	18.2% 22/121 • Number of events 25
General disorders Asthenia	6.6% 8/121 • Number of events 8
Investigations Weight decreased	10.7% 13/121 • Number of events 13

Additional Information

Jihee Mun, Pharmacist, Medical Department manager

Eisai Korea Inc.

Phone: +82-2-3451-5531

Email: jihee_mun@eisaikorea.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place